Samsung Bioepis Raises Fresh Questions For Biosimilar Interchangeability
At Least Two Of Eight Humira Biosimilars May Carry Designation
Acknowledging that “different companies have different views and approaches about interchangeability,” Samsung Bioepis has once again called into question the controversial designation.
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Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.
Prescribers must better understand how biosimilars work and why they are safe to use, in order to ensure continued biosimilar uptake, Samsung Bioepis believes.
Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.